Beclomethasone Oral Inhalation |
Beclovent (No Longer Available); QVAR; Vanceril (No Longer Available) |
Clinical Trial: Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract
This study is currently recruiting patients.
Purpose
RATIONALE: Beclomethasone may be effective in treating patients who have graft-versus-host disease of the gastrointestinal tract.
PURPOSE: Compassionate use of beclomethasone in treating patients who have graft-versus-host disease of the gastrointestinal tract that has not responded to previous therapy.
| Condition | Treatment or Intervention |
|---|---|
| Graft Versus Host Disease | Drug: beclomethasone Procedure: biological response modifier therapy Procedure: graft versus host disease prophylaxis/therapy Procedure: supportive care/therapy |
MedlinePlus related topics: Immune System and Disorders
Study Type: Interventional
Study Design: Treatment
Official Title: Compassionate Use of Oral Beclomethasone in Patients With Gastrointestinal Graft-Versus-Host Disease
OBJECTIVES:
- Provide beclomethasone dipropionate to patients with gastrointestinal graft-versus-host disease refractory to standard therapy or with a contraindication to systemic steroids.
- Minimize the serious side effects associated with systemic steroid use in these patients.
OUTLINE: Patients receive oral beclomethasone dipropionate 4 times daily for 28 days in the absence of graft-versus-host disease progression or unacceptable toxicity. Patients may then receive a second course for 31 days if symptoms of graft-versus-host disease persist. Patients may receive up to 4 treatments (1 or 2 courses each) per year.
PROJECTED ACCRUAL: A total of 24-45 patients will be accrued for this study within 3 years.
Eligibility
Ages Eligible for Study: 4 Years - 70 Years, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Clinically or pathologically confirmed graft-versus-host disease of the gastrointestinal tract
- Failed standard therapy with or has a contraindication to systemic immunosuppressive agents
- No clinically significant intestinal infection (confirmed by stool culture)
- No persistent vomiting of all oral intake
- Not a candidate for approved beclomethasone dipropionate Enteron Pharmaceuticals protocol
PATIENT CHARACTERISTICS: Age
- 4 to 70
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Able to swallow medication
PRIOR CONCURRENT THERAPY: Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- Not specified
Surgery
- Not specified
Location and Contact Information
New York
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States; Recruiting
Philip L. McCarthy, MD, Study Chair, Roswell Park Cancer Institute
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: February 2003
Last Updated: December 6, 2004
Record first received: March 6, 2003
ClinicalTrials.gov Identifier: NCT00055666
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Beclomethasone Oral Inhalation (Drug Digest)
- Beclovent (No Longer Available) (Drug Digest)

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